Matsuda, C., Munemoto, Y., Mishima, H., Nagata, N., Oshiro, M., Kataoka, M., . . . Kono, T. (2015). Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis. Cancer Chemotherapy and Pharmacology, 76, 97–103.

DOI Link

Study Purpose

To determine if TJ-1 (hangeshanshinto), a Japanese traditional herbal medicine, prevents and controls chemotherapy-induced oral mucositis

Intervention Characteristics/Basic Study Process

Patients who developed greater than World Health Organization (WHO) grade 1 oral mucositis during the first screening cycle of chemotherapy were eligible for a central 1:1 randomization to the study or control group. Three times each day, patients dissolved 2.5 g of TJ-14 or a placebo in 50 ml of water and rinsed the oral cavity. Patients were trained in the clinic. Treatment started on the first day of chemotherapy and continued for 14 days. Assessments using the WHO oral mucositis scale were done three times per week on nonconsecutive days during the screening cycle and treatment cycles 1 and 2. Assessments continued for three weeks or until mucositis returned to grade 0. Safety and adverse events were assessed.

Sample Characteristics

  • N = 90  
  • MEDIAN AGE = 67 years (range = 49–84 years) 
  • MALES: 55.5%, FEMALES: 44.5%
  • KEY DISEASE CHARACTERISTICS: Chemotherapy-induced oral mucositis in patients with colorectal cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: Fluorinated pyrimidine-based chemotherapy

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Multi-institutional, double-blinded, placebo-controlled, randomized, phase 2 trial

Measurement Instruments/Methods

  • World Health Organization (WHO) mucositis grading

Results

There was no significant difference in the incidence and severity of oral mucositis between the groups. The duration of grade ≥ 2 mucositis was 5.5 days in the treatment group and 10.5 days in the placebo group.

Conclusions

This study did not meet its primary endpoint. TJ-14 demonstrated a potential treatment effect on mucositis ≥ grade 2 .

Limitations

  • Small sample (< 100)

Nursing Implications

TJ-14 is a Japanese traditional herbal medicine consisting of a mixture of seven herbs. Additional study is needed to fully evaluate its effectiveness.